Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Estrategias económicas conductuales y de dotación de personal para aumentar la adopción del paquete ABCDEF en la UCI (BEST-ICU)

19 de octubre de 2026 actualizado por: University of Nebraska

Estrategias económicas conductuales y de dotación de personal para aumentar la adopción del paquete ABCDEF en la unidad de cuidados intensivos (BEST ICU): un ensayo controlado aleatorio de grupos escalonados

The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

Millions of survivors of critical illness worldwide experience profound and frequently persistent physical, mental, and cognitive health impairments that are often preventable through the application of existing knowledge. These impairments are commonly acquired in the intensive care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices. Indeed, ICU-acquired pain, anxiety, delirium, and weakness are associated with numerous adverse health outcomes including prolonged MV, mortality, functional decline, new institutionalization, and severe neurocognitive dysfunction. A robust body of research demonstrates that clinical outcomes improve when integrated, interprofessional approaches to MV liberation and symptom management are applied early in the course of critical illness. One such approach is the ABCDEF bundle. When applied in everyday practice, ABCDEF bundle performance is consistently associated with meaningful improvements in important patient and healthcare system outcomes. Unfortunately, ABCDEF bundle performance remains unacceptably low as clinicians struggle with multiple barriers to bundle delivery.

Investigator's previous work demonstrates bundle-related clinical decision making is indeed complex and frequently influenced by prevailing ICU social norms, common knowledge deficits, and substantial workflow challenges. Missing from the literature are evidence-based implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase bundle adoption particularly in traditionally under-resourced settings like safety net hospitals. Until this key gap in knowledge is filled, the excessively high morbidity, mortality, costs, and disparities associated with critical care delivery will continue and the public health benefit of the ABCDEF bundle will not be fully realized.

Congruent with NIH policy, the goal of this proposal is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Based on strong preliminary data, the study's overall objective is to evaluate two discrete strategies grounded in behavioral economic and implementation science theory to increase adoption of the ABCDEF bundle in critically ill adults. The strategies being evaluated target a variety of ICU team members and known behavioral determinants of ABCDEF bundle performance.

Investigators will conduct a 3-arm, pragmatic, stepped-wedge, cluster-randomized, trial to evaluate both implementation (primary) and clinical (secondary) effectiveness outcomes. After creating 6 matched pairs of 12 ICUs from 3 discrete safety net hospitals (estimated total N=16,500 patients on MV), they will randomly be assigned within each matched pair to receive either real-time audit and feedback or a Registered Nurse (RN) implementation facilitator and each pair to one of six wedges. At the end of the 27-month trial, implementation and clinical outcomes will collected for an additional 3 months to evaluate the effects of removing the implementation strategies.

Aim 1: Primary Implementation Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on proportional ABCDEF bundle performance (primary study outcome).

Aim 1: Secondary Implementation Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on complete ABCDEF bundle performance.

Aim 2: Primary Clinical Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on duration of invasive mechanical ventilation.

Aim 2: Secondary Clinical Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on other patient-centered outcomes (i.e., new tracheostomy placement; advanced non-invasive respiratory therapy use and duration; ICU, hospital, and 30-day mortality; ICU and hospital length of stay; ICU days with acute brain dysfunction (i.e., ICU delirium and/or coma); ICU physical restraint use; daily and total opioid, benzodiazepine, sedative/hypnotic, antipsychotic, melatonin receptor agonist, and paralytic medication use in ICU stay and at hospital discharge; ICU days with a family visit; discharge disposition; ICU readmission; physical therapy utilization in ICU and at hospital discharge; 30-day hospital readmission; ICU days with significant pain; unplanned extubations; reintubations within 24 hours of extubation; hospital-acquired thromboembolic disease, clinically significant falls acquired during hospitalization, hospital-acquired pressure ulcers).

Aim 3: Identify and describe key stakeholders' experiences with, and perspectives of, real-time audit and feedback and RN implementation.

Aim 3.1: Compare the effects of real-time audit and feedback and RN implementation on work intensity.

Aim 3.2: Compare the acceptability of real-time audit and feedback and RN implementation facilitation.

Aim3.3: Assess the association of work intensity with acceptability and proportional bundle performance.

Aim 3.4: Assess provider perspectives of barriers and facilitators to adoption of real-time audit and feedback and RN implementation.

Building on years of successful collaboration, investigator's experienced interprofessional team is ideally suited to perform the proposed work. Study results are expected to impact the field by developing equitable, efficient, effective, and replicable ways of accelerating the reliable uptake of the highly efficacious evidence-based ICU interventions contained in the ABCDEF bundle. This will dually address known healthcare disparities and ultimately improve the care and outcomes of millions of critically ill adults annually.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

16500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Michele C Balas, PhD, RN
  • Número de teléfono: (614) 949-5555
  • Correo electrónico: mibalas@unmc.edu

Copia de seguridad de contactos de estudio

  • Nombre: Eduard Vasilevskis, MD
  • Número de teléfono: (608) 261-1571
  • Correo electrónico: vasilevskis@wisc.edu

Ubicaciones de estudio

    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • Reclutamiento
        • University of Iowa Hospitals and Clinics
        • Contacto:
          • Anna Krupp, PhD, RN
          • Número de teléfono: (319) 467-1902
          • Correo electrónico: anna-krupp@uiowa.edu
        • Contacto:
    • Nebraska
      • Omaha, Nebraska, Estados Unidos, 68198
        • Reclutamiento
        • University of Nebraska Medical Center
        • Investigador principal:
          • Breanna D Hetland, PhD
        • Sub-Investigador:
          • Chris S Wichman, PhD
        • Sub-Investigador:
          • James R Campbell, PhD
        • Sub-Investigador:
          • Ronnie Horner, PHD
        • Sub-Investigador:
          • Jungyoon Kim, PhD
        • Contacto:
          • Michele C Balas, PhD, RN
          • Número de teléfono: (402) 559-9758
          • Correo electrónico: mibalas@unmc.edu
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43201
        • Reclutamiento
        • Ohio State University
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

19 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age > or = to 19 years at time of ICU admission
  • Received invasive mechanical ventilation while in a cluster ICU
  • Admitted to participating cluster ICU
  • Cluster ICU length of stay of at least 24 hours

Exclusion Criteria:

  • Patient who is admitted to the hospital who is already receiving chronic long-term mechanical ventilation from the home, assisted living, or long-term care setting
  • Prisoners

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual care

Usual ICU care

Experimental: Audit and Feedback

ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data

ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data

Experimental: RN Implementation Facilitator

ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation

ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportional ABCDEF bundle performance
Periodo de tiempo: 27 months

Defined as the percentage of eligible elements a patient receives on a given ICU day ["bundle dose"].

27 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Complete ABCDEF bundle performance
Periodo de tiempo: 27 months

Defined as a patient day in which every eligible element of the bundle was performed (i.e., 100% of the bundle versus anything less; yes/no).

27 months
Duration of invasive mechanical ventilation
Periodo de tiempo: 27 months

Days spent in ICU on invasive mechanical ventilation

27 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with new tracheotomy placement
Periodo de tiempo: 27 months

Current Procedural Terminology code for tracheotomy during hospitalization

27 months
advanced noninvasive respiratory therapy use and duration
Periodo de tiempo: 27 months

The recorded timestamps for advanced non-invasive respiratory therapy using CPAP, BiLevel Positive Pressure Ventilation (BiPaP), or high flow cannula with oxygen flow rates >20 lpm using a face mask or other airway that is NOT an endotracheal tube will be monitored. Specific data elements in the EHR relevant to advanced non-invasive respiratory therapy will be examined. This may include.

  • Clinical orders for the initiation of BiPaP
  • Respiratory therapy logs of pressure setting management
  • Ventilator settings and parameters recorded over time.

Once the data is organized, the duration of advanced non-invasive respiratory therapy for each patient will be calculated using the following formula:

Duration (in hours) = CPAP/BiPaP/High Flow Oxygen Initiation Time - CPAP/BiPaP/High Flow OxygenTermination Time

27 months
Number of participants with an ICU mortality
Periodo de tiempo: 27 months

A death event that is recorded in the electronic health record (EHR) that occurred after index ICU admission and prior to the index ICU discharge date and time

27 months
Number of participants with a hospital mortality
Periodo de tiempo: 27 months

A death event that is recorded in the EHR that occurred after index ICU admission and prior to discharge from the hospital on the index hospital stay.

27 months
Number of participants who die within 30 days of hospital discharge
Periodo de tiempo: 27 months

A death event that is recorded in the EHR that occurs within 30 days of the date of hospital discharge from the index hospital stay.

27 months
ICU length of stay (LOS)
Periodo de tiempo: 27 months

Date and time of ICU discharge minus the date and time of ICU admission. Each ICU stay will be recorded as unique ICU stays as a unique ICU encounter.

27 months
hospital LOS
Periodo de tiempo: 27 months

Date and time of hospital discharge minus the date and time of first encounter during the hospital encounter

27 months
ICU days with acute brain dysfunction
Periodo de tiempo: 27 months

Will record ICU days with delirium. A delirious day would include a 24-hour period with at least one Confusion Assessment Method ICU (CAM ICU) score that is measured as positive. The total would include the total number of days for which CAM ICU is measured to be positive. ICU coma days: Will record any day for which patients exhibit level of arousal scores consistent with coma (Richmond agitation/sedation score -4 or -5, Sedation agitation score of 1 or 2) and add the total number of coma days throughout any given ICU stay, and across all ICU stays within a hospitalization.

27 months
ICU days with physical restraint use
Periodo de tiempo: 27 months

Physical restraint status codes will be identified using the International Classification of Disease code Z78.1 "physical restraint status".

27 months
Opioid, benzodiazepine, sedative/hypnotic, and antipsychotic medication use in ICU and at hospital discharge
Periodo de tiempo: 27 months

Opioid, benzodiazepine, sedative/hypnotic, antipsychotic medication, and melatonin receptor agonist medication use in ICU and at hospital discharge as recorded in EHR

27 months
Discharge destination
Periodo de tiempo: 27 months

Will review hospital discharge destination coded as home, home with home health, short term skilled nursing facility, long term nursing facility, acute rehabilitation hospital, long-term acute care hospital, hospice, acute care hospital, death.

27 months
Number of participants with an ICU readmission
Periodo de tiempo: 27 months

Will be coded yes if a patient has at least one readmission to any ICU following discharge from the index ICU stay.

27 months
Number of participants with 30 day hospital readmission
Periodo de tiempo: 27 months

Coded yes if a patient has at least one hospital readmission following discharge from the index hospital stay. Importantly, will only be able to track same-hospital readmissions.

27 months
Number of participants with physical therapy use in ICU and post discharge
Periodo de tiempo: 27 months

Will collect data regarding daily interactions with physical therapy.

27 months
Days with significant pain
Periodo de tiempo: 27 months

Will define an ICU Day as having an episode of significant pain if any of the below are documented; Numeric rating score: A score of > 7 will be considered significant pain; critical care pain observation tool: A score > 2 will be considered significant pain; Behavioral pain scale: A score > 5 will be considered significant pain; Defense and Veterans Pain Rating Scale: A score > 4 will be considered significant pain; Pain in Alzheimer Disease score: A score > 4 will be considered significant pain

27 months
Number of participants with a reintubation within 24 hours of extubation
Periodo de tiempo: 27 months

Will assess for evidence of an order for intubation that occurs < 24 hours following evidence of extubation, or a prior order for extubation.

27 months
Number of participants with an unplanned extubation
Periodo de tiempo: 27 months

Will assess for evidence of extubations that do not follow provider orders for an extubation and/or are charted as unordered.

27 months
Number of participants with hospital acquired thromboembolic disease
Periodo de tiempo: 27 months

Will query for International Classification of Disease codes associated with thromboembolic disease. Diagnosis codes must be a secondary diagnosis code / hospital acquired

27 months
Number of participants with a hospital acquired fall with injury
Periodo de tiempo: 27 months

Will record fall and trauma coding consistent with the Center for Medicare Services Health Acquired Conditions specification for fracture, dislocation, and intracranial injury.

27 months
Number of participants with a hospital acquired pressure ulcer
Periodo de tiempo: 27 months

The codes for hospital acquired pressure ulcer will be consistent with the Center for Medicare Services Hospital Acquired Conditions coding.

27 months
ICU days with family visit
Periodo de tiempo: 27 months

Electronic health record documentation of family visit that occurred during ICU stay

27 months
work intensity
Periodo de tiempo: 27 months

6 item National Aeronautics and Space Administration Task Load Index; Higher scores indicate higher work intensity

27 months
acceptability
Periodo de tiempo: 27 months

4 item Acceptability of Intervention Measure; higher scores indicate greater acceptability

27 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Colaboradores

Investigadores

  • Investigador principal: Michele C Balas, PhD, RN, University of Nebraska

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2024

Finalización primaria (Estimado)

1 de abril de 2028

Finalización del estudio (Estimado)

1 de abril de 2028

Fechas de registro del estudio

Enviado por primera vez

5 de diciembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

13 de diciembre de 2023

Publicado por primera vez (Actual)

29 de diciembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 0794-23-FB
  • 1UG3HL165740-01A1 (Subvención/contrato del NIH de EE. UU.)
  • 4UH3HL165740-02 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

To support study replication and extension, all scientific data including operations and clinical data necessary for replication of this project will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first) in an appropriate online repository. Data used for analysis will be stored in comma-separated values file format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked as well. Original data will be maintained at the principal investigator's institution . There will be no restriction to sharing the data.

Marco de tiempo para compartir IPD

To support study replication and extension, all scientific data including operations and clinical data necessary for replication of this project will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first) in an appropriate online repository. Data used for analysis will be stored in comma separated values format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked. Original data will be maintained at the principal investigator's institution . There will be no restriction to sharing the data.

Criterios de acceso compartido de IPD

To support study replication and extension, all scientific data, including operational and clinical data necessary for replicating this project, will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first), in an appropriate online repository. Data used for analysis will be stored in comma-separated values format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked. Original data will be maintained at the principal investigator's institution. There will be no restriction to sharing the data.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .